Efficacy of zoledronate, denosumab or teriparatide in postmenopausal women with type 2 diabetes mellitus at high risk of fragility fractures: protocol of an open, blinded endpoint randomized controlled pilot trial.

ABSTRACT:

Background

People with type 2 diabetes (T2D) are at high risk of fragility fractures; however, there are no randomized controlled trials evaluating the efficacy of anti-osteoporosis drugs as a primary pre-specified endpoint in T2D.

Objectives

To compare the efficacy of anti-osteoporotic drugs in postmenopausal women with T2D.

Design

Prospective, randomized, open, blinded endpoint clinical pilot trial.

Methods

Postmenopausal women (⩾50 years) with T2D (duration ⩾5 years), HbA1c 7-10%, eGFR ⩾45 mL/min/1.73 m² and prior vertebral (clinical/morphometric), hip, radius, humeral fragility fracture or bone mineral density (BMD) T-score (adjusted for diabetes) at lumbar spine/femoral neck ⩽-2.5 and high FRAX score will be eligible for inclusion.

SUBMITTER: Prasad TN 

PROVIDER: S-EPMC10590540 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature